Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT04519359
Eligibility Criteria:
Key Inclusion Criteria:
* 18-65 years of old, male or female
* Chronic hepatitis B patients
* Received continuous ETV, TDF or TAF therapy for at least 1 year prior to screening and at screening
* For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAs therapy, documented hepatitis B virus \<20 IU/mL, HBeAg seroconversion and ALT normalization for at least 1 year prior to screening and at screening
* For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitis B virus \<20 IU/mL, and ALT normalization for at least 3 year prior to screening and at screening
* \<= 9 kPa on Fibroscan assessment
* qHBsAg \<200 IU/mL within 24 weeks prior to screening
* HBV RNA or HBcrAg negativity within 24 weeks prior to screening
Key Exclusion Criteria:
* Experience of IFN treatment within 1 year prior to screening
* Known cirrhosis
* History of decompensated liver disease
* History of clinical hepatic decompensation in the judgement of the investigator
* Evidence of hepatocellular carcinoma
* Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
* Known hypersensitivity to TDF, its metabolites, or formulation excipients
* History of malignant disease
* Lactating females
* Females wishing to became pregnant during the duration of the study
* Subjects participating in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04519359
Study Brief:
Protocol Section:
NCT04519359